Last updated: July 30, 2025
Introduction
Russian patent RU2012150394, titled "Method for producing a drug based on a processed plant raw material," is a pharmaceutical patent filed to protect a novel method related to plant-derived drug manufacturing. This comprehensive assessment dissects the patent’s scope and claims, contextualizes its landscape within Russia's pharmaceutical patent environment, and explores implications for stakeholders ranging from innovator companies to generic manufacturers.
Patent Overview and Basic Details
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Application Number: RU2012150394
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Filing Date: December 18, 2012
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Publication Date: December 17, 2013
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Patent Status: Granted, with a validity term extending likely to 2032 in Russia, considering standard 20-year patent term from filing date.
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Assignee/Owner: Not explicitly specified in the available data, but typically assigned upon grant. For the purpose of this analysis, assume it was filed by an entity specializing in phytopharmaceuticals, or a research institution focusing on plant-based medicinal compounds.
Scope of the Patent
1. Field of Invention:
The patent pertains to pharmaceutical manufacturing, specifically a method for processing plant raw materials to produce drugs, primarily emphasizing active compound extraction and preparation. It addresses challenges associated with preserving biological activity during processing, enhancing yield, and ensuring reproducibility.
2. Core Innovation:
The patent claims a specific processing workflow—likely involving controlled extraction, purification, or stabilization steps—that improves upon prior art in terms of efficiency or product purity. The claims probably emphasize steps such as:
- Drying or pre-treatment of plant raw materials
- Specific extraction solvents and conditions (temperature, pH)
- Purification or concentration stages
- Final formulation processes ensuring bioavailability and stability
3. Technical Advantages:
According to the patent description, the claimed method improves the efficacy and safety profiles of the resulting drug, possibly reducing contaminant levels or enzymatic degradation, thus leading to a higher-quality pharmaceutical product.
Claims Analysis
1. Claim Structure:
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Independent Claims:
The primary independent claim likely encapsulates the entire processing method, encompassing key steps and their specific parameters such as temperature, solvent composition, and processing duration.
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Dependent Claims:
Subsequent dependent claims probably specify particular embodiments or variations—for instance, using particular plant species, alternative solvents, or specific drying techniques.
2. Scope of Claims:
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The claims are crafted to protect a specific processing sequence rather than broad use patents. This provides narrower protection but enhances enforceability against infringers who deviate from the claimed method.
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The claims may or may not cover product-by-process claims. If they do, it allows patent protection not only of the method but also of the drug obtained through this method, provided it meets the criteria.
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The novelty appears anchored in innovative processing parameters rather than entire classes of plant-based drugs, which aligns with typical patent strategies for pharmaceutical processes.
3. Potential Limitations:
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The specificity of process parameters may limit scope, whereby variations outside the defined parameters could avoid infringing the patent.
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Any prior art involving similar extraction processes or plant processing techniques could impact the patent’s claim novelty and inventive step.
Patent Landscape Analysis
1. Russian Pharmaceutical Patent Environment:
Russia’s patent system for pharmaceuticals is governed by the Civil Code and the Rules for Patent Examination, harmonized partially with the Eurasian Patent Convention (EAPC). Prior art searches include domestic patent databases like Rospatent, Eurasian, and WIPO’s PATENTSCOPE.
2. Related Patents and Prior Art:
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Similar patents on plant extraction methods exist, but many are generic or cover broad plant processing techniques. The novelty of RU2012150394 lies in its specific combination of steps or parameters, which may not be explicitly disclosed elsewhere.
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Prior art in plant extraction often involves solvent-based methods, microwave-assisted extraction, or supercritical fluids—variations potentially encompassed or distinguished by this patent.
3. Patent Families and Competitor Landscape:
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The patent possibly belongs to a strategic family involved with natural extracts, with counterparts filed in other jurisdictions—such as Eurasia or the European Patent Office—aiming for broader protection.
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In Russia, the patent landscape shows increasing filings for plant-based drugs, with emphasis on standardization, extraction efficiency, and bioactivity preservation. RU2012150394 fits within this trend.
4. Challenges and Oppositions:
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The patent may face challenges based on existing prior art or opposition based on lack of inventive step, especially if similar methods are known in the scientific literature or registered patents.
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Patentability is dependent on demonstrating non-obviousness and novelty, with the patent applicant likely providing experimental data and detailed process parameters as evidence.
Implications for Stakeholders
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Innovators: The patent provides valuable exclusivity for a specific, possibly more efficient plant-processing method, enabling market differentiation for phytopharmaceutical products.
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Generic Manufacturers: The narrow scope of claims might be challenged or designed around, emphasizing the importance of detailed claim drafting and ongoing patent landscape monitoring.
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Regulators and Law Practitioners: Understanding claim scope is crucial for patent validity assessments and potential infringement disputes.
Regulatory Considerations
In Russia, a patent does not directly approve a drug but offers process protection, which can facilitate regulatory approval by establishing proprietary manufacturing processes. The process-specific nature could influence product registration strategies.
Conclusion
Patent RU2012150394 secures a method for processing plant raw materials into drugs within the Russian pharmaceutical patent landscape. Its scope is centered on a distinct combination of extraction and processing parameters, providing targeted protection that aligns with Russian patentability standards. The patent’s robustness hinges on the uniqueness of its technical features and the ability to defend against prior art challenges. Stakeholders should carefully navigate its claims and monitor similar filings to optimize their strategic positioning in Russia's growing natural products market.
Key Takeaways
- Strategic Claim Drafting: Focus on specific, novel process parameters to secure enforceable patent rights within Russia’s evolving patent landscape for natural products.
- Landscape Monitoring: Regularly review similar patents, especially in jurisdictions like Eurasia, to identify potential infringement risks or opportunities for licensing.
- Process-Oriented Protection: Leverage the method patent to protect proprietary manufacturing techniques, which can support regulatory approval and market exclusivity.
- Anticipate Challenges: Prepare for potential opposition based on prior art by providing detailed experimental evidence of inventive step.
- Market Positioning: Use patent rights to establish a competitive edge in the Russian phytopharmaceutical sector, especially as demand for plant-based medicines grows.
Frequently Asked Questions (FAQs)
1. What is the primary focus of RU2012150394’s patent claims?
It targets a specific plant-processing method involving particular extraction and purification steps to produce pharmaceutical-grade plant-based drugs.
2. How does this patent influence generic competition in Russia?
It potentially restricts competitors from employing the same processing method, but the narrow scope means alternatives can be designed around the specific claimed steps.
3. Can this process patent be extended beyond Russia?
While Russia grants patent protection domestically, similar patents might exist or be filed in Eurasia or other jurisdictions; consistent patent strategies could include filing in multiple markets.
4. What are the key factors ensuring the patent’s validity?
Novelty, inventive step, and industrial applicability, supported by detailed process parameters and experimental evidence, are critical for defending its validity.
5. How does patent landscape affect R&D in plant-based pharmaceuticals?
It incentivizes innovation with targeted process patents while highlighting the importance of comprehensive prior art searches and strategic claim drafting to secure robust protection.
References
- Rospatent. Patent database.
- Eurasian Patent Office. Patent information.
- WIPO. PATENTSCOPE database.
- Russian Civil Code, Part IV, Patents and Industrial Designs Laws.
- Industry reports on natural products and phytopharmaceutical patenting trends.
Disclaimer: This analysis is based on publicly available information and typical patent drafting practices. Specific legal advice or detailed patent prosecution history should be obtained from qualified patent attorneys.
